Trial to Evaluate the Hemostatic Effect of Lyostypt® Versus Surgicel® in Arterial Bypass Anastomosis (COBBANA)

This study has been completed.
Sponsor:
Information provided by:
Aesculap AG
ClinicalTrials.gov Identifier:
NCT00837954
First received: February 5, 2009
Last updated: July 4, 2011
Last verified: July 2011
  Purpose

The purpose of this trial is to demonstrate that the bleeding time of suture holes after construction of arterial bypass anastomosis is shorter after treatment with Lyostypt® than with Surgicel®


Condition Intervention Phase
Peripheral Vascular Diseases
Hemostasis
Device: Lyostypt® AND Surgicel®
Device: Lyostypt®
Procedure: Surgicel®
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Controlled, Prospective Trial to Evaluate the Hemostatic Effect of Lyostypt® Versus Surgicel® in Arterial Bypass Anastomosis

Resource links provided by NLM:


Further study details as provided by Aesculap AG:

Primary Outcome Measures:
  • Time to hemostasis [ Time Frame: Minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Complications [ Time Frame: 30 days after surgery ] [ Designated as safety issue: Yes ]
  • Postoperative Mortality [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
  • Efficacy Rating of Study Device evaluated by Surgeon [ Time Frame: intraoperatively ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: February 2009
Study Completion Date: April 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
distal Anastomosis Lyostypt®, proximal Anastomosis Surgicel®
Device: Lyostypt® AND Surgicel®

The investigational products are the hemostats Lyostypt® and Surgicel® (=Tabotamp® ). Lyostypt® will be provided in the size 5cm x 8cm, Surgicel® will be provided in the size 5cm x 7,5cm. The devices will be cut into half.

Lyostypt® is an absorbable wet-stable collagen compress made of collagen fibrils of bovine origin. Collagen leads to thrombocyte adhesion and to activation of coagulation factor XII.

Surgicel® absorbable Haemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. After Surgicel® has been saturated with blood, it swells into a brownish or black gelatinous mass which aids in the formation of a clot, thereby serving as a haemostatic adjunct in the control of local haemorrhage.

Other Names:
  • Lyostypt®
  • Surgicel®
Active Comparator: 2
distal Anastomosis Surgicel®, proximal Anastomosis Lyostypt®
Device: Lyostypt® AND Surgicel®

The investigational products are the hemostats Lyostypt® and Surgicel® (=Tabotamp® ). Lyostypt® will be provided in the size 5cm x 8cm, Surgicel® will be provided in the size 5cm x 7,5cm. The devices will be cut into half.

Lyostypt® is an absorbable wet-stable collagen compress made of collagen fibrils of bovine origin. Collagen leads to thrombocyte adhesion and to activation of coagulation factor XII.

Surgicel® absorbable Haemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. After Surgicel® has been saturated with blood, it swells into a brownish or black gelatinous mass which aids in the formation of a clot, thereby serving as a haemostatic adjunct in the control of local haemorrhage.

Other Names:
  • Lyostypt®
  • Surgicel®
Active Comparator: 3
distal and proximal Anastomosis Lyostypt®
Device: Lyostypt®

The investigational product is the hemostat Lyostypt®. Lyostypt® will be provided in the size 5cm x 8cm. The devices will be cut into half.

Lyostypt® is an absorbable wet-stable collagen compress made of collagen fibrils of bovine origin. Collagen leads to thrombocyte adhesion and to activation of coagulation factor XII.

Other Name: Lyostypt®
Active Comparator: 4
distal and proximal Anastomosis Surgicel®
Procedure: Surgicel®

The investigational product is the hemostat Surgicel® (=Tabotamp® ). Surgicel® will be provided in the size 5cm x 7,5cm. The devices will be cut into half.

Surgicel® absorbable Haemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. After Surgicel® has been saturated with blood, it swells into a brownish or black gelatinous mass which aids in the formation of a clot, thereby serving as a haemostatic adjunct in the control of local haemorrhage.

Other Name: Surgicel®

Detailed Description:

Hemostasis in peripheral vascular surgery is made more difficult by the need for direct arterial and arterial graft suturing as well as by systemic anticoagulation to prevent thrombosis during periods of vascular occlusion. Polytetrafluorethylene (PTFE) is one of the most frequently used graft materials for vascular replacement or bypass in the case when no autologous venae are available (1). However, the insufficient elasticity of PTFE and its porosity promote the development of suture hole bleeding (2,3) which can cause considerable loss of blood and prolongation of operations (2).

This study is designed to demonstrate the superiority of Lyostypt® to oxidized cellulose (Surgicel®) for hemostasis of suture hole bleeding in arterial bypass anastomoses after vascular reconstruction. Lyostypt® is an absorbable, wet stable collagen compress made of collagen fibrils of bovine origin. Collagen leads to thrombocyte adhesion and to activation of coagulation factor XII. Therefore collagen is very effective in hemostasis. Collagen is cell-friendly whereas other hemostats significantly disturb cell growth. Advantages of collagen fleece are fast induction of hemostasis, low tissue reaction and fast absorption (15). Furthermore, collagen was shown to be the best overall hemostatic agent in microvascular surgery. Authors concluded that collagen fleece establish faster hemostasis than oxidized cellulose and that it was resorbed faster than oxidized cellulose (15).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with an indication for a peripheral vascular reconstruction due to peripheral vascular disease (PVD) including femoro-femoral, femoro-popliteal and femoro-crural reconstructions or the need of a crossover including femoro-femoral or ilaco-femoro reconstruction.
  • suture hole bleeding of peripheral arterial bypass anastomosis using PTFE graft prosthesis
  • Written informed consent

Exclusion Criteria:

  • Emergency surgery
  • Patients with coagulopathy or uremia
  • Reoperation within one month at the same location
  • Pregnant and Breastfeeding Women
  • Known or suspected allergies or hypersensitivity to any of the used devices (e.g. to material of bovine origin)
  • Severe comorbidity (ASA ≥ 4)
  • Life expectancy less than 12 months
  • Current immunosuppressive therapy (more than 40 mg of corticoid per day or ezathioprin)
  • Chemotherapy within last 4 weeks
  • Radiotherapy on the treated region within the last 2 months
  • Severe psychiatric or neurologic diseases
  • Lack of compliance
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837954

Locations
Germany
Klinikum Hanau GmbH, Gefaesschirurgie
Hanau, Hessen, Germany, 63450
Sponsors and Collaborators
Aesculap AG
Investigators
Study Chair: Hardy Schumacher, Prof. Dr. Klinikum Hanau GmbH
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Petra Baumann, Aesculap AG & Co. KG
ClinicalTrials.gov Identifier: NCT00837954     History of Changes
Other Study ID Numbers: AAG-G-H-0803
Study First Received: February 5, 2009
Last Updated: July 4, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Aesculap AG:
PTFE Graft
Suture Hole Bleeding
Hemostasis

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014